Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of exenatide injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of exenatide injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving exenatide injection.

Pregnancy

Information about this exenatide-subcutaneous-route

Pregnancy Category

Explanation

All Trimesters

C

Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Balofloxacin

Besifloxacin

Ciprofloxacin

Enoxacin

Fleroxacin

Flumequine

Gatifloxacin

Gemifloxacin

Insulin Degludec

Levofloxacin

Lomefloxacin

Moxifloxacin

Nadifloxacin

Norfloxacin

Ofloxacin

Pazufloxacin

Pefloxacin

Prulifloxacin

Rufloxacin

Sparfloxacin

Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Digoxin

Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Diabetic ketoacidosis (ketones in the blood) or

Type 1 diabetes—Should not be used in patients with these conditions. Insulin is needed to control these conditions.

Gallstones or

Kidney disease (including kidney transplant) or

Pancreatitis (inflammation of the pancreas), history of or

Thyroid tumor—Use with caution. May make these conditions worse.

Gastroparesis (stomach does not empty food normally) or

Kidney disease, severe or

Multiple endocrine neoplasia syndrome type 2 (MEN 2) or

Stomach or bowel disease, severe or

Thyroid cancer, history of—Should not be used in patients with these conditions.